NCT01259271

Selective Nerve Stimulation (SNS) Pilot Study

Single Center, Single Blind, Randomized, Sham Controlled Pilot Study Using Selective Nerve Stimulation (SNS) Signal for Nerve Modulation With Three Amplitudes (Supra-threshold, Sub-threshold and Sham)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is right-handed the electrodes will be placed on the subject's left wrist) of the study subject. These patches will be connected by wires (leads) to a small box with a headphone jack. This is designed to provide gentle electrical stimulation through the skin. This study will look at the amount of change from normal nerve function, the sensory effects (feeling, sensations in the body), and any changes the subject has when performing the 2 hour tests. The safety of the study device will also be evaluated.

Detailed description

Single center, single blind, randomized, crossover design, sham controlled pilot study using Selective Nerve Stimulation (SNS) signal for nerve modulation with three amplitudes (supra-threshold,sub-threshold and sham) The primary objective of this proof of concept study is to: • Evaluate median nerve modulation with selective nerve stimulation amplitudes (supra-threshold, sub-threshold, and sham) by means of objective quantitative sensory tests (QST) and Sensory Nerve Conduction Threshold Tests (sNCTs) in healthy subjects. The secondary objectives to be evaluated in this study are to: * Establish device safety profile * Evaluate patient reported sensory descriptions and perception during modulation

Conditions

• Healthy
• Pain

Interventions

Type	Name	Description
DEVICE	Selective Nerve Stimulation (SNS) stimulator device	Two hours per study visit separated by a minimum of a 20 hour wash out period between stimulations.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-12-14
• Last updated: 2019-10-18

Locations

1 site across 1 country: United States